Senior Quality Assurance Engineer

Sr. Quality Engineer (Surgical Robotics / Design)

Job Description
We are seeking a Senior Quality Engineer to support the development and lifecycle management of complex medical devices in a highly regulated environment. This role will serve as a key quality partner to engineering and product development teams, helping ensure quality is built into products from concept through commercialization.
The ideal candidate will bring hands-on experience supporting electro-mechanical and software-enabled medical devices, with a strong background in design quality, risk management, validation, and regulatory compliance. This individual should be comfortable wearing multiple hats across design, development, manufacturing, and post-market quality functions.
This is a high-impact role for someone who has personally owned quality activities within product development environments and can operate effectively across cross-functional teams.

Day-to-Day
Act as the Quality representative on new product development and sustaining engineering programs
Apply design controls throughout the product development lifecycle for hardware, software, and electro-mechanical medical devices
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal quality systems
Lead and author validation documentation including process, software, equipment, and verification/validation reports
Support Design History File (DHF), design reviews, change control, and product release documentation
Drive risk management activities using ISO 14971, ensuring hazards are identified and mitigated appropriately
Participate in root cause investigations, CAPA activities, and implementation of corrective actions
Support internal/external audits and FDA inspections, serving as a subject matter expert when needed
Partner with engineering teams to ensure quality is integrated early into product design and development
Support usability, biocompatibility, electrical safety, and software compliance activities as applicable

Requirements / Qualifications
Bachelor’s degree in Engineering or related technical discipline
5+ years of Quality Engineering experience within the medical device industry
Strong experience supporting product development/design environments, not just manufacturing quality
Experience with complex electro-mechanical medical devices, capital equipment, robotics, or combination products strongly preferred
Working knowledge of FDA 21 CFR Part 820 and ISO 13485
Hands-on experience applying ISO 14971 risk management during product development
Experience leading validation efforts (process, software, equipment, test method, or product validation)
Strong knowledge of design controls, DHF documentation, design reviews, and engineering change processes
Experience participating in FDA inspections and/or ISO audits
Root cause analysis and problem-solving experience in regulated environments
Strong communication skills and ability to influence cross-functional teams

Nice to Have
Robotics or surgical system experience
Experience with IEC 62304 (software lifecycle)
Experience with IEC 60601 (electrical safety)
Experience with ISO 10993 (biocompatibility)
Experience with ISO 62366 (usability engineering)
Lead Auditor or CQE certification
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